酪氨酸激酶抑制剂 (TKI) 联合抗 PD-1 抗体 (α-PD-1) 在乙型肝炎病毒 (HBV) DNA 水平较高 (>500 IU/mL) 的晚期肝细胞癌 (HCC) 中的疗效和安全性我们回顾性评估了七家医疗机构诊断为 HBV 相关 HCC 的患者，这些患者接受 TKI 和 α-PD-1 联合抗病毒治疗。根据 HBV-DNA 水平，将患者分为高 HBV-DNA（HHBV-DNA，>500 IU/mL）或低 HBV-DNA（LHBV-DNA，≤500 IU/mL）队列。最大限度地减少组间基线不平衡。纳入了 149 名患者，其中 66 名患者的 HBV-DNA > 500 IU/mL，83 名患者的 HBV-DNA ≤ 500 IU/mL。与LHBV-DNA队列相比，HHBV-DNA队列的血清HBeAg阳性、肿瘤直径≥10 cm和血管侵犯的发生率更高。 PSM 后，每组招募了 57 名个体。 PSM 前后 HHBV-DNA 和 LHBV-DNA 队列的肿瘤学结果具有可比性。在 PSM 之前，HHBV-DNA 队列的中位 PFS 和 OS 分别为 6.1 个月和 17.5 个月，LHBV-DNA 队列的中位 PFS 和 OS 分别为 6.7 个月和 19.3 个月（所有 P > 0.05）。 PSM 后，HHBV-DNA 队列的中位 PFS 和 OS 分别为 6.0 个月和 19.5 个月，LHBV-DNA 队列的中位 PFS 和 OS 分别为 6.0 个月和 17.1 个月（均 P > 0.05）。各队列的安全性相当，未报告致命事件。七名患者 (4.7%) 出现乙型肝炎病毒再激活。 1 (0.7%) 来自 HHBV-DNA，6 (4.0%) 来自 LHBV-DNA (P = 0.134)。只有一名患者出现 HBV 相关肝炎。在同时抗病毒治疗的情况下，TKIs 加 α-PD-1 治疗 HBV-DNA > 500 IU/mL 的晚期 HCC 的有效性和安全性并未受到影响。版权所有 © 2023 Elsevier B.V. 所有保留权利。

The efficacy and safety of tyrosine kinase inhibitors (TKIs) combined with anti-PD-1 antibodies (α-PD-1) in advanced hepatocellular carcinoma (HCC) with high hepatitis B virus (HBV) DNA levels (>500 IU/mL) remain unclear.We retrospectively assessed patients from seven medical institutions diagnosed with HBV-related HCC, undergoing treatment with TKIs and α-PD-1 in conjunction with antiviral therapies. Based on HBV-DNA levels, patients were categorized into either high (HHBV-DNA, >500 IU/mL) or low HBV-DNA (LHBV-DNA, ≤500 IU/mL) cohorts Propensity score matching (PSM) was used to minimize baseline imbalance between groups.149 patients were included, with 66 patients exhibiting HBV-DNA > 500 IU/mL and 83 patients presenting HBV-DNA ≤ 500 IU/mL. Compared with the LHBV-DNA cohort, the HHBV-DNA cohort had a greater incidence of serum HBeAg positivity, tumor diameter ≥ 10 cm, and vascular invasion. Following PSM, 57 individuals were enrolled in each group. Oncological outcomes were comparable between HHBV-DNA and LHBV-DNA cohorts before and after PSM. Before PSM, the median PFS and OS were 6.1 months and 17.5 months in the HHBV-DNA cohort and 6.7 months and 19.3 months in the LHBV-DNA cohort (all P > 0.05). After PSM, the median PFS and OS were 6.0 months and 19.5 months in the HHBV-DNA cohort and 6.0 months and 17.1 months in the LHBV-DNA cohort, respectively (all P > 0.05). Safety profiles were equivalent across cohorts with no fatal incidents reported. Seven patients (4.7 %) had HBV reactivation. 1 (0.7 %) from HHBV-DNA and 6 (4.0 %) from LHBV-DNA (P = 0.134). Only one patient developed HBV-related hepatitis.The effectiveness and safety of TKIs plus α-PD-1 in advanced HCC with HBV-DNA > 500 IU/mL were not compromised in the context of concomitant antiviral therapy.Copyright © 2023 Elsevier B.V. All rights reserved.